Dental Pain
Conditions
Brief summary
The purpose of this study is to determine whether Indomethacin Test Formulation Capsules are safe and effective for the treatment of dental pain.
Interventions
DRUGCelecoxib 400 mg
Capsules 2 x 200 mg Single-Dose
DRUGPlacebo
Capsules 2 Single-Dose
DRUGIndomethacin Test (lower dose)
20-mg single dose
DRUGIndomethacin Test (upper dose)
40-mg single dose
Sponsors
Iroko Pharmaceuticals, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Patient is male or female between 18 and 50 years of age * For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control * Patient requires extraction of 2 or more third molars * Patient must be willing to stay at the study site for at least 8 hours after dosing of the study drug
Exclusion criteria
* Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs * Patient has a current disease or history of a disease that will impact the study or the patient's well-being * Patient has used or intends to use any of the medications that are prohibited by the protocol * Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test * Patient has taken another investigational drug within 30 days prior to Screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Patient Pain Relief Over 0 to 8 Hours. | 8 hours | Total patient pain relief was assessed as a time-weighted sum of the patient pain assessments at each individual time point from 0-8 hours. Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 32. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Indomethacin Test (Lower Dose) | 50 |
| Indomethacin Test (Upper Dose) Single dose | 51 |
| Celecoxib 400 mg | 51 |
| Placebo | 51 |
| Total | 203 |
Baseline characteristics
| Characteristic | Indomethacin Test (Upper Dose) | Celecoxib 400 mg | Indomethacin Test (Lower Dose) | Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 51 Participants | 50 Participants | 51 Participants | 203 Participants |
| Age Continuous | 22.2 years STANDARD_DEVIATION 3.81 | 22.1 years STANDARD_DEVIATION 3.46 | 22.0 years STANDARD_DEVIATION 3.32 | 22.1 years STANDARD_DEVIATION 2.97 | 22.1 years STANDARD_DEVIATION 3.38 |
| Region of Enrollment United States | 51 participants | 51 participants | 50 participants | 51 participants | 203 participants |
| Sex: Female, Male Female | 31 Participants | 34 Participants | 32 Participants | 35 Participants | 132 Participants |
| Sex: Female, Male Male | 20 Participants | 17 Participants | 18 Participants | 16 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 19 / 50 | 26 / 51 | 19 / 51 | 29 / 51 |
| serious Total, serious adverse events | 0 / 50 | 0 / 51 | 0 / 51 | 0 / 51 |
Outcome results
Primary
Total Patient Pain Relief Over 0 to 8 Hours.
Total patient pain relief was assessed as a time-weighted sum of the patient pain assessments at each individual time point from 0-8 hours. Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 32.
Time frame: 8 hours
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Indomethacin Test (Lower Dose) | Total Patient Pain Relief Over 0 to 8 Hours. | 10.794 units on a scale |
| Indomethacin Test (Upper Dose) | Total Patient Pain Relief Over 0 to 8 Hours. | 12.564 units on a scale |
| Celecoxib 400 mg | Total Patient Pain Relief Over 0 to 8 Hours. | 14.822 units on a scale |
| Placebo | Total Patient Pain Relief Over 0 to 8 Hours. | 3.019 units on a scale |
p-value: <0.00195% CI: [5.816, 13.275]ANCOVA